BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 19466442 · Received June 5, 2024

    Report

    Report Number
    1723170-2024-01427
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    April 16, 2023
    Report Date
    July 1, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H2: SEE D4, G2. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ONUMA, H., SAKAI, K., ARAI, Y., TORIGOE, I., TOMORI, M., SAKAKI, K., HIRAI, T., EGAWA, S., KOBAYASHI, OKAWA, A., YOSHII, T. AUGMENTED REALITY SUPPORT FOR ANTERIOR DECOMPRESSION AND FUSION USING FLOATING METHOD FOR CERVICAL OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT. JOURNAL OF CLINICAL MEDICINE. 2023. 12 (2898). HTTPS://DOI.ORG/10.3390/JCM12082898. ABSTRACT: ANTERIOR DECOMPRESSION AND FUSION (ADF) USING THE FLOATING METHOD FOR CERVICAL OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT (OPLL) IS AN IDEAL SURGICAL TECHNIQUE, BUT IT HAS A SPECIFIC RISK OF INSUFFICIENT DECOMPRESSION CAUSED BY THE IMPINGEMENT OF RESIDUAL OSSIFICATION. AUGMENTED REALITY (AR) SUPPORT IS A NOVEL TECHNOLOGY THAT ENABLES THE SUPERIMPOSITION OF IMAGES ONTO THE VIEW OF A SURGICAL FIELD. AR TECHNOLOGY WAS APPLIED TO ADF FOR CERVICAL OPLL TO FACILITATE INTRAOPERATIVE ANATOMICAL ORIENTATION AND OPLL IDENTIFICATION. IN TOTAL, 14 PATIENTS WITH CERVICAL OPLL UNDERWENT ADF WITH MICROSCOPIC AR SUPPORT. THE OUTLINE OF THE OPLL AND THE BILATERAL VERTEBRAL ARTERIESWAS MARKED AFTER INTRAOPERATIVE CT, AND THE RECONSTRUCTED 3D IMAGE DATA WERE TRANSFERRED AND LINKED TO THE MICROSCOPE. THE AR MICROSCOPIC VIEW ENABLED US TO VISUALIZE THE OSSIFICATION OUTLINE, WHICH COULD NOT BE SEEN DIRECTLY IN THE SURGICAL FIELD, AND ALLOWED SUFFICIENT DECOMPRESSION OF THE OSSIFICATION. NEUROLOGICAL DISTURBANCES WERE IMPROVED IN ALL PATIENTS. NO CASES OF SERIOUS COMPLICATIONS, SUCH AS MAJOR INTRAOPERATIVE BLEEDING OR REOPERATION DUE TO THE POSTOPERATIVE IMPINGEMENT OF THE FLOATING OPLL, WERE REGISTERED. TO OUR KNOWLEDGE, THIS IS THE FIRST REPORT OF THE INTRODUCTION OF MICROSCOPIC AR INTO ADF USING THE FLOATING METHOD FOR CERVICAL OPLL WITH FAVORABLE CLINICAL RESULTS. REPORTABLE EVENTS: THE ERROR IN LOCATING THE POINTS BETWEEN THE MAPPING SOFTWARE AND THE NAVIGATION SYSTEM WAS 0.9 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815208 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male